Loading clinical trials...

A Study on the Potential Benefit of Neoadjuvant Therapy for AGC Patients | Clinical Trials | Clareo Health

UNKNOWN

A Study on the Potential Benefit of Neoadjuvant Therapy for AGC Patients

A Prospective Observational Study on the Potential Benefit of Neoadjuvant Therapy for Advanced Gastric Cancer Based on Organoid Drug Susceptibility Screening

NCT05442138•Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

Early gastric cancer（AGC）has no effective characteristic symptoms and signs according to clinical statistics. Neoadjuvant chemotherapy (NAC) significantly reduces the size of AGC tumors so that it has become the recommended treatment for AGC in major guidelines. However, Some patients miss the best time for surgical treatment and may have irreversible chemotherapy side effects due to NAC lacks the guidance of new indicators for precise treatment such as molecular biomarkers. Tumor organoids are highly consistent with the clinical drug sensitivities of patients which could be used as clinical treatment prediction models thus providing guidance for individualized medicine. Therefore, the project is the first to carry out the prospective study by screening the potential benefit populations of NAC based on tumor organoids drug susceptibility experiment. The following hypothesis are put forward：the potential benefit population of NAC screened by tumor organoid drugs susceptibility technology will have better clinical efficacy, better treatment tolerance and higher adverse reaction rate.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18-75 years old;
•2. Qualitative diagnosis: gastroscopic biopsy confirmed adenocarcinoma;
•3. Localization diagnosis: the tumor is located in the stomach or gastroesophageal junction;
•4. The clinical staging is stage III:
•A. Assess tumor stage: T3-4N1-2; B. Excluding distant organ metastasis (M0);
•5. Physical condition (ECOG) score ≤ 1 point;
•6. Those with effective preoperative neoadjuvant therapy and successful surgery agreed to receive 5 cycles of standard SOX chemotherapy after surgery;
•7. Sign the informed consent form and be willing to participate in this project.

Exclusion Criteria

•1. Simultaneous or metachronous multiple primary malignant tumors;
•2. Preoperative imaging examination results showed that there was distant metastasis;
•3. Preoperative imaging findings:
•A. The tumor involving surrounding organs requires combined organ resection; B. Distant organ metastases; C. Those who cannot perform R0 resection;
•4. Past history of malignant tumor;
•5. Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy;
•6. Mental illness or other serious cardiovascular disease;
•7. Pregnant or lactating women.

Key Dates

Start Date

August 1, 2022

Primary Completion Date

May 1, 2023

Completion Date

June 1, 2024

Last Updated

July 29, 2022

Enrollment

ESTIMATED participants

Conditions

Early Gastric CancerTumor Organoids

Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients

NCT04665687

Early Gastric CancerGastric Adenoma

View study

RECRUITING

Multimodal Deep Learning for Lymph Node Metastasis Prediction and Physician Performance Assessment in T1 Gastric Cancer

NCT07124754

T1 Gastric Cancer Lymph Node Metastasis Early Gastric Cancer Artificial Intelligence-Assisted Diagnosis Multimodal Data Integration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study on the Potential Benefit of Neoadjuvant Therapy for AGC Patients

Inclusion Criteria

Exclusion Criteria

Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients

Multimodal Deep Learning for Lymph Node Metastasis Prediction and Physician Performance Assessment in T1 Gastric Cancer

Explainable Machine Learning for Predicting Early Gastric Cancer

A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer

Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors

Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study